CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Coated Vicryl (Polyglactin 910) Suture, 18" Product recalled by Ethicon
Ethicon is recalling Coated Vicryl (Polyglactin 910) Suture, 18", distributed nationwide in the US. The recall was initiated on 3 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0989-2020
- FDA event ID
- 84639
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jan 2020
- FDA classified
- 4 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 3 Jan 2020 | Recall initiated by company | |
| 4 Feb 2020 | Classified by FDA | +32 days |
| 12 Feb 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Product as listed by the FDA
Coated VICRYL (Polyglactin 910) Suture, 18" (45cm) Product Code J497H. The device is a synthetic absorbable sterile surgical suture.
Where it was distributed
Domestic distribution nationwide. US and Puerto Rico only.
Questions about this recall
Why was it recalled?
Some sutures in the lot may exhibit a small section of braid fraying, which can lead to reduced tensile strength at that point.
Which lots are affected?
lot PGZ908
Where was it sold?
Domestic distribution nationwide. US and Puerto Rico only.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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